An interventional study of Laproscopic posterior mesh rectopexy (Wells or LPMR) and Laparoscopic lateral mesh rectopexy (Orr-Loygue) in Posterior Laparoscopic, Lateral Laparoscopic and Rectopexy, sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-19.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
Aim of the study is to evaluate the outcomes of two different methods of mesh placement during laparoscopic rectopexy for the management of complete rectal prolapse lateral versus posterior mesh rectopexy
Rectal prolapse is the full-thickness prolapse of the rectum, in which the rectum passes externally beyond the anal sphincters. It is a somewhat rare condition, estimated to occur in less than 0.5% of the population. Rectal prolapse has a 9:1 female predominance, and while it is occasionally seen in younger individuals, the incidence increases with age.
Surgical approaches for rectal prolapse can be divided into perineal and abdominal approaches. Traditionally, a perineal procedure such as Delorme or Altemeir operation was commonly used in elderly or frail patients while an abdominal procedure such as rectopexy with or without resection was reserved for younger and fitter patients. The frequency of laparoscopic abdominal repair of rectal prolapse has increased in recent years, with mesh rectopexy being the most popular procedure.
The mesh rectopexy operation was first described by Ripstein10 in 1952. Again, after mobilization of the rectum, an anterior sling of synthetic material (either absorbable or non-absorbable) is placed in front of the rectum and sutured to the sacral promontory. The rationale for this is to restore the natural curve of the rectum, which reduces the effect of downward abdominal pressure. The use of a non-elastic synthetic graft provides a firm anterior fascial support even in patients with significant pelvic floor descent, returning the rectum to a normal anatomical position.
The act of mobilization, suture, and fibrosis keeps the rectum fixed in position as adhesions form, attaching the rectum to the presacral fascia. Although SR is considered a good option for the cure of rectal prolapse/IS in both men and women, some reviews of this procedure noted a better overall clinical outcome in men. This may be due to occult sphincter defects in women, and failure to detect these defects before surgery owing to the lack of routine endoanal ultrasonography in the earlier years of prolapse surgery
55 studies on the registry are indexed under Rectal Prolapse; 12 are open to participants now.
This study's planned enrollment of 30 is below the median of 55 across 34 interventional studies indexed under Rectal Prolapse.
Browse Rectal Prolapse studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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Contraindication
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After complete rectal mobilization, a mesh is inserted between the sacrum and the posterior rectum, sutured into the rectum, and fixed to the promontory. The mortality rates ranged from 0% to 1.2%, and recurrence rates ranged from 0% to 11% There was an overall improvement in continence (74%-100%), with conflicting results regarding constipation. New-onset constipation in 5% to 44% of patients was reported
Procedure: Laproscopic posterior mesh rectopexy (Wells or LPMR)
This procedure involves complete mobilization of the rectum with two mesh strips sutured laterally to the rectal wall on both sides, and they were suspended to the promontory. There are several studies on this procedure using a laparoscopic approach. Lechaux et al. performed laparoscopic Orr-Loygue rectopexy in 35 patients. Incontinence improved in 27% of patients, and constipation improved in 19% but worsened in 27%. The recurrence rate was 3% (1/35) after a mean follow-up of 36 months. A study on 46 patients with laparoscopic Orr-Loygue procedure with posterior mobilization found a significant reduction in incontinence score after 1 year, but there were no changes in the use of laxatives. The recurrence rate was 4% after a median follow-up of 1.5 years.
Procedure: Laparoscopic lateral mesh rectopexy (Orr-Loygue)
After complete rectal mobilization, a mesh is inserted between the sacrum and the posterior rectum, sutured into the rectum, and fixed to the promontory. The mortality rates ranged from 0% to 1.2%, and recurrence rates ranged from 0% to 11% There was an overall improvement in continence (74%-100%), with conflicting results regarding constipation. New-onset constipation in 5% to 44% of patients was reported
This procedure involves complete mobilization of the rectum with two mesh strips sutured laterally to the rectal wall on both sides, and they were suspended to the promontory. There are several studies on this procedure using a laparoscopic approach. Lechaux et al. performed laparoscopic Orr-Loygue rectopexy in 35 patients. Incontinence improved in 27% of patients, and constipation improved in 19% but worsened in 27%. The recurrence rate was 3% (1/35) after a mean follow-up of 36 months. A study on 46 patients with laparoscopic Orr-Loygue procedure with posterior mobilization found a significant reduction in incontinence score after 1 year, but there were no changes in the use of laxatives. The recurrence rate was 4% after a median follow-up of 1.5 years
Operative time
Operative time will be measured (Time Frame: from inflation of abdomen till deflation in laparoscopic repair and from skin incision up to skin closure in open repair)
Time frame: Until the conclusion of the surgical procedure
Intraoperative injuries
Intra operative injuries will be recorded including bowel or vascular injuries
Time frame: Until the conclusion of the surgical procedure
Improving of symptoms
Laparoscopic lateral mesh rectopexy versus posterior mesh rectopexy regarding to improving of symptoms will be recorded
Time frame: 28 days after surgery
Recurrence rate
Laparoscopic lateral mesh rectopexy versus posterior mesh rectopexy regarding to recurrence rate will be recorded The recurrence rate was 3% (1/35) after a mean follow-up of 36 months in laparoscopic lateral mesh rectopexy (Orr-Loygue) and recurrence rates ranged from 0% to 11% in laproscopic posterior mesh rectopexy (Wells or LPMR)
Time frame: 28 days after surgery
Complications
Complications will be recorded such as early as bleeding, incontinence, intestinal obstruction, late as constipation, sexual dysfunction, intestinal obstruction, erosion of mesh
Time frame: 28 days after surgery
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
Time frame: ِِِAfter the end of study for one year.
Access criteria: The data will be available upon a reasonable request from the corresponding author
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Started Aug 2024 (actual). Primary completion is estimated for Oct 2026, 25 months after the start.
Of 18 interventional studies with no phase under Rectal Prolapse, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 94. This study's planned 25 months is below that.
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